Iterum Therapeutics US FDA Approval On October 25, 2024, Iterum Therapeutics (ITRM) announced that the U.S. FDA has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem, etzadroxil, and probenecid) for the treatment of the uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved …

Astellas Pharma Inc Announcement Tokyo, Oct. 18, 2024, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) announced that the United States FDA has approved VYLOY (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) …

AbbVie FDA Approval for VYALEV for Parkinson’s Disease AbbVie (ABBV) announced that the U.S. FDA  approved VYALEV™ (foscarbidopa and levodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). From the Experts Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s and Movement Disorder Center at …

Novo Nordisk Childhood Obesity Prevention Initiative  From Bagsværd, Denmark, on October 8, 2024, Novo Nordisk (NVO) announced a new global initiative to prevent obesity in children. The Childhood Obesity Prevention Initiative aims to accelerate the prevention of childhood obesity in disadvantaged urban communities globally. Together with partners, which include city governments, academic institutions, and non-profit organizations, the initiative will support six cities in designing, implementing, …

IntraBio Inc in the NEWS  IntraBio Inc. announced that the FDA has approved AQNEURSA (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.  IntraBio Inc., a US biopharmaceutical company, focused on the development of novel drugs addressing rare and common neurological diseases. IntraBio’s platform technologies result from decades of research and collaboration with …

 Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301 On August 28, 2024,  Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech (KRYS) announced positive interim safety and efficacy results from both Cohorts 3 and 4 of PEARL-1, a Phase 1 study evaluating KB301, an investigational aesthetic treatment designed to deliver the COL3A1 transgene and increase type III collagen (“COL3”) levels in the …

Galderma: FDA Approval for Nemluvio® Today, August 13, 2024, Galderma (GALD.SW) announced that the U.S. FDA has approved its product Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis.  Galderma exists in approximately 90 countries. It delivers an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable …

SCG Cell Therapy FDA Approval SCG Cell Therapy Pte Ltd (SCG) is a biotech company developing novel immunotherapies for infectious diseases and their associated cancers, announced that United States FDA has approved its investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142 – a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors. From SCG Cell Therapy Christy Ma, Chief …

From Mitsubishi Tanabe Pharma America Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at Mitsubishi Tanabe Pharma America said, “We are excited to be at the Congress of the European Academy of Neurology (EAN) this year to showcase our  research and engage with its scientific community. The findings highlight our dedication to advancing the understanding of investigational ND0612 and our commitment to recognizing …

US FDA Approval for AstraZeneca’s IMFINZI AstraZeneca (AZN): The trial results of the FDA newly approved combination products demonstrated a reduction in the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.   Endometrial cancer is the fourth most common cancer in women In the United States.  More than 66,000 patients diagnosed and almost 12,000 deaths in …

Regeneron in the NEWS Regeneron Pharmaceuticals (REGN) announced today that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks, and initial hearing improvements were observed in a second child (dosed at 4 years of age) at a 6-week assessment. Both children were born with profound genetic deafness due to variants of the …

INmune Bio Press Release  INmune Bio (NASDAQ: INMB) is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three years under the Australian compassionate use program known as the Special Access Scheme (SAS).  Both patients, herein referred to as “Patient 1” and “Patient 2,” was …

Cerevel Therapeutics in the NEWS Cerevel Therapeutics (CERE) announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as once a day treatment for Parkinson’s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa  in adults. The trial met its primary endpoint. Patients …

Italfarmaco in the NEWS  From Milan, Italy: Today, Italfarmaco announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat) – a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD) – a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood. From Italfarmaco Paolo Bettica, MD, PhD, Chief Medical Officer …

Abbott Laboratories New PROTALITY™ for Maintaining Muscle Mass During Weight Loss Abbott Laboratories (ABT) announced the launch of its new PROTALITY™ brand. The high-protein nutrition shake is the first product to support the adults interested in pursuing weight loss while maintaining muscle mass and good nutrition. Half of U.S. adults attempted to lose weight in the past year.  Whether pursuing weight loss by taking GLP-1 medications, …

Sanofi to Acquire Inhibrx Inc Paris, January 23, 2024, Sanofi (SNY) and Inhibrx, Inc. (INBX) entered into a definitive agreement under which Sanofi agreed to acquire Inhibrx following the spin-off of non-INBRX-101 assets into New Inhibrx. INBRX-101 is a human recombinant protein that holds the promise of allowing Alpha-1 Antitrypsin Deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. …

Cognition Therapeutics CEO Letter to Shareholders Cognition Therapeutics (CGTX) today announced that CEO Lisa Ricciardi has issued a Letter to Shareholders to provide an update on recent pipeline developments and a preview of the company’s strategy in 2024. The full text of the letter: A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER To my fellow shareholders, The year ahead holds great promise for Cognition Therapeutics. We …

AbbVie Inc UBRELVY Results Published in The Lancet AbbVie Inc (ABBV) announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. The Phase 3 study, PRODROME, showed that UBRELVY given during the prodrome (i.e., 1-6 hours before the predicted onset of headache pain) significantly reduced the …

Akero Therapeutics Presented at the H.C. Wainwright 7th Annual NASH Conference Indeed, today, Akero Therapeutics (AKRO) presented virtually at the H.C. Wainwright 7th Annual NASH Conference on Tuesday, October 24, 2023, at 12:00 p.m. E.T. A live webcast of the fireside chat will be available through the investor relations section of the Company’s website at www.akerotx.com In case you missed the live webcast, an archived …

Johnson & Johnson’s Janssen Pharmaceutical AKEEGA Johnson & Johnson (JNJ) owned Janssen Pharmaceutical announced that the U.S. FDA has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), which no longer responds to androgen deprivation therapy and has spread to other …